Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also
Medical device recall Z-1618-2014. Published in FDA’s Enforcement Report on May 21, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 21, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 79 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
2008-Series Hemodialysis Machines with Revision K Actuator Test Boards may fail to detect a disconnected Ultrafiltration (UF) Pump
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
79 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Revision K Actuator Test Boards S/N of 2008 T Machines: 3T0S124903 3T0S124937 3T0S124933 3T0S124986 3T0S124934 3T0S124970 3T0S124894 3T0S124935 3T0S124912 3T0S124965 3T0S124944 3T0S124988 3T0S124939 3T0S124990 3T0S124940 3T0S124941…
Every code shown here, 924 characters
Revision K Actuator Test Boards S/N of 2008 T Machines: 3T0S124903 3T0S124937 3T0S124933 3T0S124986 3T0S124934 3T0S124970 3T0S124894 3T0S124935 3T0S124912 3T0S124965 3T0S124944 3T0S124988 3T0S124939 3T0S124990 3T0S124940 3T0S124941 3T0S124958 3T0S124888 3T0S124946 3T0S124999 3T0S124942 3T0S124991 3T0S125023 3T0S124951 3T0S124936 3T0S124895 3T0S124955 3T0S125000 3T0S124943 3T0S125010 3T0S124893 3T0S124954 3T0S124896 3T0S124899 3T0S124959 3T0S125008 3T0S124947 3T0S125018 3T0S124905 3T0S124961 3T0S124898 3T0S124907 3T0S124963 3T0S124891 3T0S124952 3T0S125028 3T0S124920 3T0S124966 3T0S124910 3T0S124909 3T0S124967 3T0S124901 3T0S124953 3T0S125029 3T0S124922 3T0S124969 3T0S124913 3T0S124911 3T0S124972 3T0S124902 3T0S124960 3T0S124930 3T0S124925 3T0S125011 3T0S124921 3T0S124916 3T0S124979 3T0S124918 3T0S124962 3T0S124945 3T0S124926 3T0S125013 3T0S124927 3T0S124917 3T0S124984 3T0S124928 3T0S124968 3T0S124964 3T0S124932
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
USA (nationwide) and the country of Canada.*
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 25, 2014.
- FDA classified it on May 13, 2014.
- FDA’s Enforcement Report published it on May 21, 2014.
- FDA terminated it on May 18, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fresenius Medical Care Holdings, Inc., of Waltham, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.